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Epclusa(velpatasvir)
Epclusa, Vosevi (velpatasvir) is a small molecule pharmaceutical. Velpatasvir was first approved as Epclusa on 2016-06-28. It is used to treat chronic hepatitis c and hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Combinations
Epclusa, Vosevi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sofosbuvir
+
Velpatasvir
Tradename
Company
Number
Date
Products
EPCLUSAGilead SciencesN-208341 RX2016-06-28
2 products, RLD, RS
EPCLUSAGilead SciencesN-214187 RX2021-06-10
2 products, RLD, RS
Sofosbuvir
+
Velpatasvir
+
Voxilaprevir
Tradename
Company
Number
Date
Products
VOSEVIGilead SciencesN-209195 RX2017-07-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
epclusaNew Drug Application2021-03-26
sofosbuvir and velpatasvirNDA authorized generic2021-06-21
voseviNew Drug Application2019-11-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic hepatitis cEFO_0004220D019698B18.2
hepatitis c—D006526B19.2
Agency Specific
FDA
EMA
Expiration
Code
SOFOSBUVIR / VELPATASVIR, EPCLUSA, GILEAD SCIENCES INC
2028-12-10PED
2028-06-10ODE-376
2027-09-19PED
2027-03-19ODE-293
2025-04-27M-277
2024-01-14PED
2023-09-19PED
2023-07-14M-264
2023-05-15PED
2023-03-19NPP, NS
Patent Expiration
Patent
Expires
Flag
FDA Information
Sofosbuvir / Velpatasvir / Voxilaprevir, Vosevi, Gilead Sciences Inc
109128142037-06-01DP
113380072037-06-01DPU-2039, U-2040
92967822034-07-17DS, DP
98687452032-11-16DS, DP
89570462028-03-21U-2039, U-2040
95859062028-03-21DS, DPU-2039, U-2040
Sofosbuvir / Velpatasvir, Epclusa, Gilead Sciences Inc
97574062034-01-30DP
100860112034-01-30U-1470
111167832034-01-30DPU-1470, U-2039, U-2040
85751352032-11-16DS, DPU-1470, U-2039, U-2040
89213412032-11-16DS, DPU-1470, U-2039, U-2040
89407182032-11-16DS, DPU-1470, U-2039, U-2040
86180762030-12-11DS, DPU-1470, U-2039, U-2040
92843422030-09-13DS, DPU-1470, U-2039, U-2040
79645802029-03-26DS, DPU-1470, U-2039, U-2040
86333092029-03-26DS, DPU-1470, U-2039, U-2040
88891592029-03-26DPU-1470, U-2039, U-2040
83342702028-03-21DS, DPU-1470, U-2039, U-2040
85807652028-03-21DS, DPU-1470, U-2039, U-2040
87353722028-03-21U-1470, U-2039, U-2040
90855732028-03-21DS, DPU-1470, U-2039, U-2040
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AP: Antivirals for treatment of hcv infections
— J05AP55: Sofosbuvir and velpatasvir
— J05AP56: Sofosbuvir, velpatasvir and voxilaprevir
HCPCS
No data
Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526B19.248315735
Chronic hepatitis cD019698EFO_0004220B18.232—11218
Hiv infectionsD015658EFO_0000764B20———314
Opioid-related disordersD009293EFO_0005611F11———4—4
Hepatitis bD006509———134
Chronic hepatitis bD019694EFO_0004197B18.1———112
Liver neoplasmsD008113EFO_1001513C22.0———2—2
Liver diseasesD008107EFO_0001421K70-K77———2—2
HivD006678O98.7———2—2
Metabolic bone diseasesD001851HP_0000938———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CryoglobulinemiaD003449EFO_0005846D89.1—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung diseasesD008171EFO_0003818J98.411———1
Chronic kidney failureD007676EFO_0003884N18.6—1———1
Liver transplantationD016031EFO_0010682—1———1
Kidney transplantationD016030—1———1
Heart failureD006333EFO_0003144I50—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Deglutition disordersD003680HP_0002015R13.11————1
HepacivirusD0161741————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal diseasesD012164HP_0000479H35.9————11
Pregnancy complicationsD011248————11
Treatment adherence and complianceD000074822————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVELPATASVIR
INNvelpatasvir
Description
Velpatasvir is a complex organic heteropentacyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with sofosbuvir (under the brand name Epclusa) for treatment of patients with chronic hepatitis C of all six major genotypes. It has a role as an antiviral drug and a hepatitis C virus nonstructural protein 5A inhibitor. It is an organic heteropentacyclic compound, a N-acylpyrrolidine, a L-valine derivative, a carbamate ester, a member of imidazoles, a ring assembly and an ether.
Classification
Small molecule
Drug classantivirals: nonstructural protein 5A (NS5A) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Identifiers
PDB—
CAS-ID1377049-84-7
RxCUI1799206
ChEMBL IDCHEMBL3545062
ChEBI ID—
PubChem CID67683363
DrugBankDB11613
UNII IDKCU0C7RS7Z (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vosevi - Gilead Sciences
$
€
£
₣
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Epclusa - Gilead Sciences
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,421 documents
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Safety
Black-box Warning
Black-box warning for: Epclusa, Sofosbuvir and velpatasvir, Vosevi
Adverse Events
Top Adverse Reactions
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1,263 adverse events reported
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